1. ISO 9001 : 2000

2. Objective Introduce the concept of ISO 9001 Standard
Highlight important areas of ISO 9001 Standard
Briefly introduce the system requirements of ISO 9001 Standard

3. What is ISO 9001: 2000
Quality Management System Requirement Standard from International Organization for Standards
Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994
Introduced considerable conceptual changes
Applicable to all types of Organizations with possible permissible omissions of certain requirements

4. Continual Improvement cycle
ISO 9001:2000
QMS
Management
Responsibility
General requirements
Resource
management
Measurement,
analysis &
improvements
Product
Realization
Continual Improvement cycle

5. CUSTOMERS CUSTOMERS ISO 9001 : 2000 – Model 5.Management
Continual Improvement of
the Quality Management System
Quality Management
System
5.Management
Responsibility
8. Measurement
Analysis and
Improvement
6. Resource
Management
CUSTOMERS
CUSTOMERS
Satisfaction
7. Product
Realization
Requirements
Product
Consumption

6. Principles of ISO 9001:2000
Customer focus
Leadership
Mutual beneficial supplier relationship
Involvement of people
Based on eight quality management principles
Factual approach to decision making
Process approach
System approach to Management
Continual improvement

7. Principles of ISO 9001:2000 Customer focus Leadership
Organization depends customers
Understand current & future customer needs.
Meet / exceed customer expectations
Leadership
Leaders establish purpose & direction of the organization
Should create & maintain environment to achieve organization’s objectives
Involvement of People
People of all levels are essence of an organization
Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and resources are managed as process

8. Principles of ISO 9001:2000 Continual improvements
System approach to Management
Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s overall performance should be a permanent objective of the organization
Factual approach to decision making
Effective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships
An organization & its suppliers are interdependent
Mutually beneficial relationship enhances the ability of both to create value

9. Expectations of ISO 9001:2000
Avoid the application of systems that are separate from the organization’s business process
Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business
Enable Continual improvements of the system for enhanced customer satisfaction
Enable compliance to statutory & regulatory requirements

10. Process approach Process definition
Set of interrelated or interacting activities which transforms inputs into outputs
Identify the processes
Identify the Inputs & outputs
Identify the Interactions to other processes
Establish measuring criteria
Ensure continual improvements
Do it for all value adding processes

11. Process approach – Continual improvements of Process
Understandings &
meeting requirements
PLAN
PDCA Cycle
Processes in terms
Of Added Value DO
Continual improvements
of Processes based on
objective measurements
ACTION
Measure results of process
Performance and effectiveness
- Objective Measurements
CHECK

12. E.g. - Purchasing Process
Procedure
Inputs
Required item / quantity / date
Applicable specs
Supplier source
Suppliers capability to meet our requirements
Outputs
Receipt of Material on right condition
Right Quality Right Quantity
Right Time
Interactions to
Storage
Inspection and Testing
Manufacturing
Finance
Performance Measurements
Delivery status – On-time, On spec, NCP etc
Supplier evaluation

13. System Requirements / Structure of the Standard
4 Quality Management System
5 Management Responsibility
6 Resource Management
7 Product Realization
8 Measurement Analysis & improvement
Management Commitment
Customer focus
Quality policy
Planning
Responsibility, authority & communication
Management Reviews
General requirements
Documentation Requirements
Provision of resources
Human resources
Infrastructures
Work environment
Planning
Customer related processes
Design & development
Purchasing
Production & service provision
General
Monitoring & measurement
Control of NCP
Analysis of data
Improvements

14. 4 - Quality management system
Identification
of processes
required
Continual
improvements
4.1 General
requirements
Criteria and
methods to ensure
Operation & control
Monitoring and
Measuring of
processes
Availability of
information &
resources for
operation & control

15. 4 - Quality management system
4.2 Document requirements
Quality Policy
Quality Objectives
Quality Manual
Procedures required by the Standard
Procedures required for planning, operation & control of Organization activities
Records

16. 5 - Management Responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility authority & communicate
5.6 Management Review
Quality objectives
QMS planning
Internal communication
Management representative
Responsibility & authority
General
Review inputs
Review outputs

17. 5 - Management Responsibility
Development, implementation and continually improvement of QMS
Establishment of
Quality Policy
Quality Objectives
Top Management’s commitment
Identification of Customer requirements
Appointment of Management
Representative
Conducting Management Reviews
Providing required resources
Communication of importance of
Regulatory & statutory requirements
Meeting customer requirements
Quality Policy & Quality objectives
Responsibilities & authorities

18. 5 - Management Responsibility
Evidence must be provided to show that the Management is committed to the above requirements
Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system

19. 6 - Resource Management 6.1 Provision of resources 6.2 Human Resources
6.3 Infrastructures
6.4
Work Environment
General
Competence, awareness & training

20. 6 - Resource Management Resources required to Human Resources
Implementing, monitoring & continual improvements
Enhance Customer satisfaction by meeting customer requirements
Human Resources
Resource Management
Infrastructures
Infrastructures needed to achieve product conformity
Work environment
Work environment needed to achieve product conformity

21. 6 - Human Resources 6.2 Human Resources Enhanced
Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
6.2 Human Resources
Provide training or actions
Evaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed

22. 7 - Product Realization 7.1 Planning of product realization 7.2
Customer related processes
7.3
Design and development
7.4
Purchasing
7.5
Production & service provision
7.6
Control of monitoring measuring devices
Identification of customer requirement
Review of customer requirement
Customer communication
Design planning
Design inputs
Design outputs
Design review
Design Changes
Design validation
Design verification
Verification of purchased products
Purchasing process
Purchasing information
Control
Preservation of product
Validation of processes
Identification & traceability
Customer property

23. 7 - Product Realization 7.1 Planning of Product realization
Quality objectives of Products – Specs
7.1
Planning of Product realization
Processes, procedures to realize product
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformance

24. 7 - Product Realization 7.2 Customer related processes – (Sales)
Identification of Customer / Market requirements
Specified by customer
Requirements taken for granted
Statutory / Regulatory requirements
7.2
Customer related processes – (Sales)
Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements
Effective communication with customer in relation to
Product information
Sales order handling
Customer feedback
Customer complaints

25. Design and Development – (Product)
7 - Product Realization
Planning
Effective & efficient
Expectations of interested parties
EHS
7.3
Design and Development – (Product)
Design inputs and outputs
Review and verification, validation and control of changes
Accuracy
Potential hazards & faults
Corrections
Evaluations against lessons learned

26. Clause 7.3 Design Process Design plan 7.3.1 Design Review 7.3.4 C U UT O M E R U S E R
Design Input
7.3.2
Design Output
7.3.3
Design Process
Design verification
7.3.5
Design validation
7.3.6
Design changes
7.3.7

27. 7 - Product Realization 7.4 Purchasing
Degree of control depends on effects of subsequent processes and effect on final product
7.4
Purchasing
Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
Supplier evaluation
Verification of purchased product – Inspection and testing

28. 7 - Product Realization Product characteristics (Specs)
Procedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
7.5
Production and service provision
Manufacturing / service provision under controlled condition to ensure conformity of product
Product release, delivery and post delivery
Process validation
Identification and traceability
Customers property
Material supplied by customers – e.g.. 3rd party blending

29. 7 - Product Realization
7.6 Control of monitoring and measuring devices
Control and Calibration of equipments used for monitoring, inspection and testing

30. 8 - Measurement, analysis and improvement
Control of non conforming product
8.1
General
8.2
Monitoring & measurements
8.4
Analysis of data
8.5
Improvement
Measurement of product
Internal audits
Customer satisfaction
Measurement of processes
Corrective action
Preventive action
Continual improvements

31. 8 - Measurement, analysis and improvement
To demonstrate
Conformity of the product
Conformity to QMS requirements
Continually improvements and the effectiveness of the system
8.1 - To demonstrate
Conformity of the product
Conformity to QMS requirements
Continually improvements and the effectiveness of the system
Monitoring and Measurements
Customer satisfaction / perception
Internal audits - conformity planned arrangements of QMS and ISO9001
Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results
Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP
To assure that NCP products are identified and controlled to prevent unintended use / delivery

32. 8 - Measurement, analysis and improvement
8.4 - Analysis of data
Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system
Analysis shall provide information related to
Customer satisfaction / perception
Conformity to specs, requirements
Trends of processes and products
Opportunities for preventive actions
Suppliers

33. 8 - Measurement, analysis and improvement
8.5 - Improvements
Continual Improvements
QMS needed to be continually improved
Corrective action
Actions to prevent recurrence of NCP, NCR etc
Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records
Preventive action
Actions against potential non conformities to avoid their occurrence
Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records

34. Criteria for measurements
Satisfaction surveys for customers and other interested parties
Feedback on products
Customer & market requirements
Financial measurements
Prevention cost
Non conforming / failure cost
Lifecycle cost
System performance
Self assessment
Internal audits
Effectiveness & efficiency of processes
Opportunities for improvements
Use of data / information
Effective & efficient use of resources
Adequacy, accuracy and performance of measurements
Relationships with customers/ suppliers/ other interested parties

35. Criteria for measurements
Process capability / process validation
Reaction time
Cycle time / throughput (Capacity)
Utilization of technology
Waste reduction
Cost reduction
Processes
Products
Inspection and testing of incoming, in process and final product
Product verification
Product validation

36. Pros and Cons More business oriented. Less procedure oriented
Company wide involvement
Mutual benefit to all interested parties
Customer focus than product focus
Continual improvements
Less emphasis on documentation
More resource demanding ??

37. Challenges in implementing ISO 9001:2000
Management Support
Encouragement
ISO 9001:2000
Other employee Support
Communication

38. Thank You